Clinical trials: Pharmacology, Clinical
Alcohol Dependence, Alcohol Use Disorder
Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users
Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs.
- Trial name
- NCT02445339
- Testing
- XR-NTX+CM (Extended-Release Naltrexone plus Care Management)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NYU Langone Health
Japanese Patients With ALS
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
- Trial name
- NCT04176224
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Shionogi
Clinical Pharmacology
TAK-114 Single- and Multiple-Dose Phase 1 Study
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
- Trial name
- NCT02286518
- Testing
- TAK-114 10 mg capsule
- Where
- Japan
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Takeda
Primary Alcohol Use Disorder
Ketamine for Reduction of Alcoholic Relapse
96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple…
- Trial name
- KARE (NCT02649231)
- Testing
- Ketamine, Psychological Therapy, Alcohol Education
- Where
- 2 sites in United Kingdom
- Volunteers
- 96 people
- Sponsor
- University College, London
Healthy Adult Subjects
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males Cohort 2: To evaluate the pharmacokinetics, safety…
- Trial name
- NCT04481789
- Testing
- MT-1186, Rosuvastatin, Sildenafil
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy
Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates
This study consisted of 2 parts: Part 1 and 2. The purpose of this study was to evaluate the pharmacokinetic, safety and tolerability of multiple doses of evobrutinib on single doses of digoxin, metformin and rosuvastatin in…
- Trial name
- NCT05064488
- Testing
- Evobrutinib (45mg), Digoxin (0.25mg), Metformin (10mg)
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
HIV
Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics
This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection.
- Trial name
- NCT01386970
- Testing
- zidovudine 300mg and lamivudine 150mg as Combivir
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
In Vitro Fertilization
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a…
- Trial name
- NCT00696800
- Testing
- Corifollitropin alfa, RecFSH / Follitropin beta (Days 1 to 7), RecFSH / Follitropin beta (Days 8 to hCG)
- Volunteers
- 1,509 people
- Sponsor
- Organon and Co
Healthy
Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants
The purpose of this study was to assess the effect of multiple doses of carbamazepine on single- dose tepotinib pharmacokinetics in healthy participants.
- Trial name
- NCT05213481
- Testing
- Tepotinib, Carbamazepine
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Pancreatic Neoplasms, Pancreatic Cancer
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
This is a phase II study. It is designed to provide information about if high-dose ascorbate (vitamin C) increases survival for pancreatic cancer patients.
- Trial name
- PACMAN-II (NCT01515046)
- Testing
- Gemcitabine with escalating ascorbic acid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Joseph J. Cullen
Subarachnoid Hemorrhage, Stroke
Clinical, Pharmacological and Molecular Effects of IV and Oral Acetaminophen in Adults With aSAH
This study compares the bioavailability of IV and PO acetaminophen in both blood and the cerebrospinal fluid (CSF) of patients following subarachnoid hemorrhage.
- Trial name
- aSAH (NCT02549716)
- Testing
- IV acetaminophen, Oral acetaminophen
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Milton S. Hershey Medical Center
Schizophrenia, Obesity
Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
The aims of this study were to evaluate the efficacy of an intervention for weight gain management for patients from schizophrenia spectrum compared to treatment as usual (TAU), and to evaluate the effects of this program on…
- Trial name
- NCT01368406
- Testing
- wellness program
- Where
- 4 sites in Brazil
- Volunteers
- 160 people
- Sponsor
- Federal University of São Paulo
Healthy
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive
The purpose of this study was to assess the effect of M2951 on the pharmacokinetics (PK) of a combined oral contraceptive [Ethinyl estradiol/Norethisterone (EE/NET)] in healthy female participants.
- Trial name
- NCT07215806
- Testing
- Evobruitnib, Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese…
- Trial name
- NCT01202071
- Testing
- Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets, Rabeprazole sodium, 20 mg Tablets
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Restless Legs Syndrome
Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome
This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.
- Trial name
- NCT00530790
- Testing
- ropinirole controlled release (CR)-RLS
- Where
- 11 sites in Japan
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline
Colitis, Ulcerative
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130…
- Trial name
- NCT03100864
- Testing
- Spesolimab
- Where
- 4 sites in Belgium, Germany and 1 more
- Volunteers
- 8 people
- Sponsor
- Boehringer Ingelheim
Healthy
The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.
- Trial name
- NCT01112670
- Testing
- Sitagliptin, atorvastatin
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Child, Hospitalized
Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
To evaluate whether an integration of pharmacological and non- pharmacological interventions is more effective than either one of intervention in pain reduction during pediatric peripheral venipuncture.
- Trial name
- NCT04275336
- Testing
- EMLA application, Distraction techniques, EMLA cream and distraction techniques
- Where
- China
- Volunteers
- 354 people
- Sponsor
- Children's Hospital of Fudan University
Schizophrenia
A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses
To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.
- Trial name
- NCT04118127
- Testing
- 2mg conventional tablet, once-weekly tablets
- Where
- Japan
- Volunteers
- 73 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Perinatal Depression, Perinatal Anxiety
Cognitive Behavioral Couple Therapy for Perinatal Distress
The hypotheses of the study are There will be differences in perceived perinatal distress, dyadic coping strategies, social support, domains of quality of life, and well-being in couples at Pre- and Post-Test levels during the…
- Trial name
- NCT06001021
- Testing
- Psychopharmacological Intervention, Cognitive Behavioral Couple Therapy, Combination of Psychopharmacological Intervention and CBCT
- Where
- Pakistan
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Sameera Shafiq